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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K041347
Device Name MODIFICATION TO EN-BLOC BIOPSY SYSTEM
Applicant
Neothermia Corp.
One Apple Hill Suite 316
Natick,  MA  01760
Applicant Contact SHERRIE COVAL-GOLDSMITH
Correspondent
Neothermia Corp.
One Apple Hill Suite 316
Natick,  MA  01760
Correspondent Contact SHERRIE COVAL-GOLDSMITH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/20/2004
Decision Date 06/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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